Conditioning Regimen in Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Stopped early · Phase 2
Conditions studied: Renal Cell Cancer
In brief
Primary Objectives: 1. To compare the overall survival of metastatic renal cell carcinoma (RCC) patients undergoing HLA-matched related donor nonmyeloablative allogeneic hematopoietic stem cell transplantation (NST) using fludarabine-melphalan (FM) versus fludarabine-cyclophosphamide (FC) conditioning regimen. 2. To assess both cytotoxic T lymphocyte reactivity and antibodies activity against potential tumor antigenic peptides involved in graft-versus-RCC effect. Secondary Objectives: 1. To study the patient characteristics of metastatic RCC patients who undergo NST and those who do not undergo NST. 2. To compare the incidence of Day-100 treatment-related mortality in FM group and FC group.
Key facts
- Study ID
- NCT00429026
- Run by
- M.D. Anderson Cancer Center
- People needed
- 40
- Starts
- 2004-01-01
- Expected to finish
- 2008-03-01
- Last updated by the study team
- 2013-03-04
Who can join
Age: any, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- For registration: Willing to undergo allogeneic transplantation.
- For registration: Age equal to or less than 65 years old.
- For registration: Metastatic RCC with predominant conventional cell type.
- For registration: Prior nephrectomy.
- For registration: Stage IV RCC. If patient has prior single brain metastasis treated with complete surgical resection or stereotactic radiation therapy, no recurrence or brain edema from the end of treatment for at least 6 months has to be shown by radiological imaging.
- For registration: Zubrod performance status < one.
- For registration: Potential related donor for allogeneic stem cell transplantation.
- For registration: At least one prior treatment for metastatic RCC. Radiation therapy or surgery is not counted as a treatment.
- For registration: Signed an informed consent.
- For transplantation: Zubrod performance status < one.
- For transplantation: An HLA-matched (defined as 6/6 matches) related donor.
- For transplantation: Failed at least one prior treatment for metastatic RCC. Radiation therapy or surgery is not counted as a treatment.
- For transplantation: Adequate major organ functions (see section 4.17-4.20).
- For transplantation: Signed an informed consent for allogeneic stem cell transplantation.
You may not qualify if…
- For registration: Prior history of allogeneic stem cell transplantation.
- For registration: Histologic feature with predominant non-conventional cell type.
- For registration: Multiple brain metastasis.
- For registration: Life expectancy is severely limited by concomitant illness.
- For transplantation: Multiple brain metastasis.
- For transplantation: Life expectancy is severely limited by concomitant illness.
- For transplantation: Clinically significant active infections.
- For transplantation: HIV infection.
- For transplantation: Chronic active hepatitis
- For transplantation: Pregnant or lactating women.
- For transplantation: Has all three risk factors: high serum lactate dehydrogenase, low hemoglobin, high corrected serum calcium.
Where it is running
- U.T. M.D. Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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